Travere Therapeutics reached an agreement Tuesday on what data the Food and Drug Administration would require to approve its drug, Filspari, for a second kidney disease.
Travere is planning to ask the FDA to sign off on Filspari as a treatment for focal segmental glomerulosclerosis, or FSGS, in the first quarter. FSGS causes scarring on specific parts of the kidneys. Filspari is already approved to treat patients with IgA nephropathy, another kidney condition.
"An approval not only opens the door for broader Filspari uptake, but would seemingly increase the potential for M&A (mergers and acquisitions) interest," Wedbush analyst Laura Chico said in a report.
The news sent Travere stock flying 12.6% to 23.75. Shares are now flirting with a profit-taking zone after breaking out of a double-bottom base with a buy point at 19.99, according to MarketSurge.
Travere Therapeutics Nears Potential Approval
Travere Therapeutics plans to use already completed studies called Duplex and Duet to clinch approval of Filspari in FSGS treatment. A working group examining FSGS' treatment, called Parasol, found reductions in proteinuria — the amount of protein in urine — led to improvements in FSGS symptoms.
"We do see the Parasol data providing support for the utility of proteinuria-based endpoints in FSGS," Wedbush's Chico said. "Moreover, with Filspari showing consistent proteinuria benefits versus irbesartan, we see a high probability of success for advancement."
Irbesartan treats high blood pressure and can help treat kidney problems.
Chico expects Filspari to gain approval for this use in late 2025, and boosted her price target on Travere stock to 30 from 25. She has an outperform rating on Travere Therapeutics shares.
Highly Rated IBD 50 Stock
Travere stock hit its highest point since late 2022 on the news. Shares rank No. 16 on the IBD 50 list of elite growth stocks.
Notably, Travere Therapeutics carries an IBD Digital Relative Strength Rating of 98 out of a top 99. This means shares rank in the top 2% of all stocks when it comes to 12-month performance.
Follow Allison Gatlin on X/Twitter at @AGatlin_IBD.
